cholecalciferol supplementation in strengthening inspiratory muscles in cholecalciferol-deficient patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Muscle Weakness

Summary: this phase iib randomized trial studies how well cholecalciferol (vitamin d3) supplementation works in strengthening inspiratory muscles in cholecalciferol-deficient patients with chronic obstructive pulmonary disease (copd). cholecalciferol supplementation may help reduce the risk of developing lung cancer and strengthen the diaphragm in cholecalciferol-deficient patients with copd.

primary objectives: i. to establish the effect of d vitamin (vitamin d3) supplementation on inspiratory muscle strength in vitamin d3-deficient chronic obstructive pulmonary disease (copd) patients. (roswell park cancer institute \[rpci\]/university at buffalo \[ub\] study) ii. to establish the 12 month conversion rate. (university of pittsburgh cancer institute \[upci\] study) secondary objectives: i. to establish the effect of vitamin d3 supplementation on peripheral muscle strength and exercise capacity in vitamin d3-deficient copd patients. (rpci/ub study) ii. to establish the 3 and 6-month conversion rates. (upci study) iii. to examine whether vitamin d3 supplementation is equally effective in copd patients who are current versus former smokers. (upci study) tertiary objectives: i. to explore the effects of vitamin d3 supplementation in copd patients on biomarkers of lung cancer risk, inflammation, and pulmonary function. (upci study) outline: patients are randomized to 1 of 2 arms. control arm: patients receive a placebo and multivitamin orally (po) once daily (qd) for 52 weeks. supplementation arm: patients receive a multivitamin and cholecalciferol supplement po qd for 52 weeks. after completion of study treatment, patients are followed up for 1 year.

Eligibility criteria:
inclusion criteria: * current or ex-smoker with at least a 10-year pack history * copd, defined as forced expiratory volume in 1 second (fev1)/forced vital capacity (fvc) \< 70% and fev1% predicted \< 80% * 25-hydroxy vitamin d3 (25\[oh\]d3) level less than 20 ng/ml prior to study initiation * willingness to comply with study guidelines * willingness to avoid alternative/additional vitamin d3 supplementation for the duration of the trial * subject must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure exclusion criteria: * personal history of lung cancer or head and neck cancer * history of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue) * history of known thyroid disease * history of known sarcoid disease * history of known abnormalities in calcium metabolism * hypercalcemia (serum calcium in excess of laboratory upper limit normal \[uln\]) * self-reported consumption of more than 4 alcoholic drinks per day * use of anti-seizure medications phenobarbital or phenytoin, which can disrupt vitamin d metabolism * history of known renal dysfunction * history of known nephrolithiasis (kidney stones) * current use of supplemental oxygen * inability to exercise due to musculoskeletal issue, osteoarthritis or underlying cardiac disease * current participation in a cancer intervention prevention study, except for smoking cessation * any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug * inability to swallow pills * vitamin d supplementation \> 2,000 iu/day of vitamin d within 30 days prior to enrollment * positive pregnancy test

Keywords: current smoker former smoker